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Navigating Advanced Therapy Medicinal Product regulatory changes: European Medicines Agency and UK guidance updates
Abstract
The regulatory landscape for advanced therapy medicinal products (ATMPs) continues to evolve in the EU and the UK. The European Medicines Agency (EMA) unified guideline (effective July 2025) and the UK Post-Windsor Framework guidance (effective January 2025) have established current requirements, while revisions to EU Good Manufacturing Practice (GMP) Part IV remain under consultation.
This article summarises the practical implications of these developments for ATMP developers, highlighting how sponsors can align submissions, maintain compliance and optimise development programmes in 2026.
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